Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD

Launched by OCON MEDICAL LTD. · Jan 12, 2014

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

• Inclusion criteria:
• • Adult females aged 18-45
• • Free and willing to fully comply with treatment process
• • Healthy women seeking LARC
• • Married or in a steady relationship (at least 1 year)
• • Blood hemoglobin \>11.5gr/dL
• • Signed informed consent form
• • If took COCP at least had one cycle after use of OC
• Exclusion criteria:
• • Use IUB/IUD as an emergency contraception
• • A previously placed IUD that has not been removed
• • Pregnancy or suspicion of pregnancy
• • Immediately post-abortion or post-partum - unless had at least one free cycle
• • Use of other contraception method (condom for either male or female, oral contraceptives, diaphragms, spermicides, hormonal patches, injections or ring, cervical cap)
• • History of pelvic inflammatory disease, recent or remote.
• • Postpartum endometritis or postabortal endometritis in the past 3 month
• • Mucupurulent cervicitis
• • Endometrial thickness more than 12 mm on insertion date
• • Known anemia (except thalassemia, sickle cell, chronic anemia)
• • Severe Mennorrhagia or severe Dysmenorrhea
• • History of previous IUD complications
• • Dysfunctional uterine bleeding
• • Undiagnosed uterine bleeding
• • Malignancy or suspected malignant disease of female inner or outer genitalia
• • Distortions of the uterine cavity by uterine fibroids or known anatomical abnormalities
• • Known intolerance or allergy to nitinol or copper and/or copper IUDs - Wilson's disease.
• • Medication that may interfere with the subject's ability to complete the protocol
• • Use of injectable contraception in the previous year
• • Any other significant disease or condition that could interfere with the subject's ability to complete the protocol
• • A history of alcohol or drug abuse
• • Known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
• • Pregnancy or pregnancy planned during the year
• • Enrollment (less than 30 days after completing another study) in or planned to be enrolled in another study